MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE EZ; POWERED LASER SURGICAL INSTRUMENT

Model Number	0642-393-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual analysis of the returned fiber found that the fiber was received in one piece, also, it was noticed that there was an internal connector fracture, since there were no signs of light exiting the connector, therefore the reported event was confirmed.The fiber connector internal fracture could lead to an insufficient aiming beam or low laser energy output and up to a complete inability for the fiber to fire.A fracture within the connector could occur due to procedural handling of the fiber during setup or use.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on these observations, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during preparation for a ureteral lithotripsy, it was identified that there was no energy output when using the fiber.The procedure was completed with another fiber without patient complications.After the fiber was analyzed, it was found an internal connector fracture.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19265488
• Report Number: 2124215-2024-27556
• Device Sequence Number: 6981560
• Product Code: GEX
• UDI-Device Identifier: 17290109140169
• UDI-Public: 17290109140169
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0013810323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 54 KG